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XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial, GlaxoSmithKline Australia Pty Ltd, CON-874

Product name
XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial
Sponsor name
GlaxoSmithKline Australia Pty Ltd
ARTG details
  • 364110
Consent start
Consent no.
CON-874
Duration
The consent is effective from the 15th October 2021 until 17 August 2023.
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that key relevant information (as would be required under TGO 91) is absent from the labels.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines